High performance mouthguard

ABSTRACT

Described herein is a high performance mouthguard. Generally, the mouthguard includes a tray formed from a non-softenable material. The tray generally includes an arched wall comprising a top, a bottom, a lingual surface, and a facial surface and, in addition to the arched wall, at least one generally vertical recess in at least a portion of the lingual surface. The mouthguard further includes a generally arched trough formed from a heat-softenable material. Generally, the trough includes an arched t wall comprising a lingual surface and a facial surface. Moreover, the trough includes at least one member protruding from the facial surface that is positioned and shaped to fit within the at least one recess of the tray.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 61/350,330, filed Jun. 1, 2010, which is hereby incorporated byreference in its entirety.

BACKGROUND

A number of mouthguards currently exist in the art for protecting theteeth and for reducing the chance of shock, concussions, and otherinjuries as a result of high impact collisions and blows during athleticcompetition. Mouthguards generally are characterized as beingnon-personalized, universal and stock model type, or are formed to havedirect upper jaw tooth-formed contact. These are customizablemouthguards.

Additionally, the mouthguards may be tethered or untethered. Mouthguardsmay be tethered to a fastening point, such as a helmet or face guard, toprevent the chance of the mouthguard from being lost as well as toprevent swallowing of the mouthguard or choking on the mouthguard by theuser.

The lack of a mouthguard or the use of an improperly fitted mouthguardhave been found to be responsible for illnesses and/or injuriesresulting from impacts, collisions, or blows that occur to the jawstructure of an athlete. Such injured athletes are susceptible toheadaches, presence of earaches, ringing in the ears, clogged ears,vertigo, concussions and dizziness. The cause of these types of healthproblems and injuries are generally not visible by inspection of themouth or the jaw but more particularly relate to the temporomandibularjoint (TMJ) and surrounded tissues where the lower jaw is connected tothe skull in the proximity where the auriculo-temporalis nerves andsupra-temporo arteries pass from the neck into the skull to the brain.

In addition to protection of the teeth and the TMJ, athletes clenchtheir teeth during exertion, which can result in hundreds of pounds ofcompressed force exerted from the lower jaw onto the upper jaw. Suchclenching can result in headaches, muscle spasms, damage to teeth,injury to the TMJ, and pain in the jaw. Furthermore, clenching of theteeth makes breathing more difficult during physical exercise.

Most importantly, many problems exist with prior mouthguards.Mouthguards with a rigid labial or buccal walls do accept wide teeth,were bulky and had sharp edges. When the custom appliances were placedin hot water to soften for fitting, the mouthguards tended to collapseand permit portions to touch and stick together upon removal from thehot water thus making fitting of such mouthguards always a problem.Delamination and chewing destruction caused short life of themouthguards.

SUMMARY OF THE INVENTION

The present invention provides a mouthguard. Generally, the mouthguardincludes a tray formed from a non-softenable material. The traygenerally includes an arched wall comprising a top, a bottom, a lingualsurface, and a facial surface and, in addition to the arched wall, atleast one generally vertical recess in at least a portion of the lingualsurface. The mouthguard further includes a generally arched troughformed from a heat-softenable material. Generally, the trough includesan arched wall comprising a lingual surface and a facial surface.Moreover, the trough includes at least one member protruding from thefacial surface that is positioned and shaped to fit within the at leastone recess of the tray.

In some embodiments, at least one recess extends to the top of thelingual surface. In other embodiments, at least one recess extends tothe bottom of the lingual surface.

In some embodiments, a cross section of the recess can define an openingin the lingual surface having a lingual surface width, and a cavityhaving a cavity width that is generally parallel to the lingual surfacewidth. In certain embodiments, the cavity width is greater than thesurface width.

In some embodiments, a cross section of the recess can define an openingin the lingual surface, and a recess depth that is generallyperpendicular to the lingual surface, wherein the recess depth is greatenough to permit the tray to flex in a plane generally axial to therecess.

In some embodiments, fitting the trough member into the tray recessreduces delamination of the trough from the tray.

The above summary of the present invention is not intended to describeeach disclosed embodiment or every implementation of the presentinvention. The description that follows more particularly exemplifiesillustrative embodiments. In several places throughout the application,guidance is provided through lists of examples, which examples can beused in various combinations. In each instance, the recited list servesonly as a representative group and should not be interpreted as anexclusive list.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates an exploded perspective view of an exemplaryembodiment of a mouthguard.

FIG. 2 illustrates a top view of an exemplary embodiment of a mouthguardcomponent.

FIG. 3 illustrates a rear view of an exemplary embodiment of amouthguard component.

FIG. 4 illustrates a front view of an exemplary embodiment of amouthguard component.

All Figures are illustrated for ease of explanation of the basicteachings of the present invention only; the extensions of the Figureswith respect to number, position, relationship and dimensions of theparts to form the embodiment will be explained or will be within theskill of the art after the following description has been read andunderstood. Further, the exact dimensions and dimensional proportions toconform to specific force, weight, strength, and similar requirementswill likewise be within the skill of the art after the followingdescription has been read and understood.

Where a numeral is used in various Figures of the drawings, the numeraldesignates the same or similar parts in the various Figures in which itis used.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

The present invention provides a mouthguard that can offer improveddurability compared to existing mouthguards. Multi-componentmouthguards—i.e., mouthguards formed from two or more components thatare affixed, adhered, or otherwise attached to one another to form themouthguard—are susceptible to delamination of the components.Delamination affects the mouthguard's ability to provide the desiredperformance and/or protective function for which it is designed.Delamination decreases the useful life and, therefore, negativelyaffects the durability of the mouthguard.

The mouthguard described herein includes at least two connectedcomponents. One component is formed from a heat-softenable materialthat, in use, is fitted over and/or around the dentition of a user. Asecond component is formed from non-softenable material that provides,at a minimum, support for the heat-softenable component. These twocomponents are attached to one another by, at a minimum, a system of oneor more members protruding from the heat-softenable material that fitwithin corresponding one or more recesses in the second component,forming a male-female fit that at least partially secures the twocomponents to one another.

In some cases, one or more of the recesses can possess a generallyvertical orientation so that the recess forms a natural flexion point inthe non-softenable material. Thus, a recess can provide two distinctfunctions within the mouthguard. First, a recess can provide the femaleportion of a male-female fit as described in the immediately precedingparagraph. Additionally, by providing flexion about the z-axis, a recesscan improve flexibility of the mouthguard to provide better and morecomfortable fit over a wider range of user arches.

As used herein, the following terms shall have the indicated meanings:

“Arched” refers to having a form like that of an arch, particularly atleast a portion of a dental arch such as, for example, the maxillaryarch.

“Heat-softenable” refers to materials that soften and become moldablewhen heated to a temperature within a glass transition temperature rangeof from about 120° F. to about 200° F.

“Non-softenable” refers to materials that do not soften and becomemoldable when heated to a temperature of 200° F. or less.

The term “and/or” means one or all of the listed elements or acombination of any two or more of the listed elements.

The terms “comprises” and variations thereof do not have a limitingmeaning where these terms appear in the description and claims.

Unless otherwise specified, “a,” “an,” “the,” and “at least one” areused interchangeably and mean one or more than one.

Also herein, the recitations of numerical ranges by endpoints includeall numbers subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2,2.75, 3, 3.80, 4, 5, etc.). Furthermore, when the terms “top,” “bottom,”“right,” “left,” “forward,” “rearward,” “front,” “rear,” “first,”“second,” “inside,” “outside,” “upper,” “lower,” “inferior,” “superior,”“anterior,” “posterior,” “proximal,” “distal,” “facial,” “buccal,”“labial,” “oral,” “lingual,” “palatal,” “mesial,” and similar positionaland/or relative terms are used, the terms should be understood toreference the structures shown in the drawings as they will typically beutilized by one skilled in the art or otherwise as would be recognizedby one skilled in the art.

Moreover, various embodiments are described. Unless embodiments aremutually exclusive or unless otherwise indicated, a mouthguard caninclude the features of any two or more embodiments described herein.

The present invention generally provides a mouthguard that may be customfit to the dentition of a user. The mouthguard generally includes aheat-softenable material shaped to fit over the teeth of the maxillaryarch. In use, the heat-softenable material may be heated sufficiently tosoften the material so that the heat-softenable material is moldablearound the teeth of the maxillary arch. The heat-softenable material maybe placed over the teeth of the maxillary arch and then molded to thedentition of the user and then allowed to cool to produce a mouthguardcustom fit to the user. The molding of the softened heat-softenablematerial may be performed by the user forcing the maxillary teeth intothe softened heat-softenable material.

Custom fitting the mouthguard can involve immersing the mouthguard intowater that has been heated to or above the glass transition temperatureof the heat-softenable material. In some cases, the water may beboiling. In other cases, however, the water may be heating to asub-boiling temperature and still be warm enough to soften the heatsoftenable material.

After the heat-softenable material has been softened, the mouthguard canbe inserted into the mouth and registered with the maxillary arch. Theuser then exerts a force pressing the maxillary teeth into the softenedheat-softenable material, thereby causing the heat-softenable materialto conform to the contours of at least a portion of the user's maxillaryteeth and, optionally, at least a portion of the user's gums. The usermay exert the force by providing a biting force to the mouthguard.Alternatively, the user may exert the force by pressing the mouthguardupwardly into the maxillary teeth with the tongue or a finger.

Referring now to the Figures, an exploded view of a mouthguard 10 isgenerally shown in FIG. 1. The mouthguard 10 includes at least twocomponents: a trough 20 formed at least in part from a heat-softenablematerial and a tray 30 fowled at least in part from a non-softenablematerial. Exemplary heat-softenable materials and exemplarynon-softenable materials are described in more detail below. In someembodiments, the mouthguard 10 can include one or more components inaddition to the trough 20 and tray 30 that are shown in FIG. 1. Suchadditional components may be mouthguard components such as, for example,one or more components described in detail in one or more of U.S. Pat.Nos. 6,505,626; 6,505,627; 6,505,628; 6,508,251; 6,510,853; 6,588,430;6,675,806; 6,675,807; 6,691,710; and 7,299,804.

As shown in FIG. 2 and FIG. 3, the tray 30 includes a generally archedwall 32 having a top 34, a bottom 36, a facial surface 38, and a lingualsurface 40. The tray 30 further includes at least one recess 42 in atleast a portion of the lingual surface 40.

The tray 30 can include any number of recesses 42. In some embodiments,the tray 30 may include a single recess 42. In other embodiments,however, a tray 30 can include, for example, two, three, four, five,six, seven, eight, nine, ten, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20recesses 42. In embodiments that include multiple recesses 42, the size,shape, and/or disposition on the lingual surface 40 of each recess 42may be independent of the size, shape, and/or disposition on the lingualsurface 40 of any other recess 42.

A recess 42 can assume a variety of shapes, sizes, orientations, anddispositions along the lingual surface 42 of the tray 30. For example, arecess 42 may extend to the top 34 of the lingual surface 40, as shownin FIG. 1 and FIG. 2. Alternatively, a recess 42 may extend to thebottom 36 of the lingual surface 40, as shown in FIG. 3. In otherembodiments, a recess 42 may extend to both the top 34 and bottom 36 ofthe lingual surface 40 or, in alternative embodiments, reach neither thetop 34 nor bottom 36 of the lingual surface 40.

A recess 42 can have any suitable shape. In some embodiments, a recess42 may be generally circular or ovoid 42′, as illustrated in FIG. 2. Inother embodiments, a recess 42 may be polygonal 42″ such as, forexample, generally rectangular, pentagonal, hexagonal, etc. as shown inFIG. 2. Polygonal recesses 42 are also illustrated in FIG. 1 and FIG. 3.

In cross section, illustrated in the top view of FIG. 2, a recess 42 candefine an opening 44 at the lingual surface 40 having a lingual surfacewidth 46. As used herein, the lingual surface width 46 is the shortestdistance from one edge of the recess 42 to the other edge of the recess42 across the recess opening 44 and generally co-planar with the lingualsurface 40. In cross section, a recess 42 can further define a cavity 48having a cavity width 50. As used herein, the cavity width 50 is thegreatest diameter across the cavity 48 that is generally parallel to thelingual surface width 46. As used herein, diameter refers to a straightline passing from side to side of a cavity 48 regardless of the geometryof the cavity 48.

In some embodiments, a recess 42 may be configured so that the cavitywidth 50 is greater than the lingual surface width 46 of the recess 42.In such embodiments, insertion of trough member 28 into the recess 42forms a male-female fit that can help maintain the integrity of thetray-trough assembly and, therefore, decrease the likelihood and extentto which the tray 30 and trough 20 might delaminate during use. Thestructural integrity provided to a tray-trough assembly generallyincreases as the number of recess-member fits increases, at least withinthe range of recess-member fits typically present in a mouthguard 10.

In some embodiments, a recess 42 can define an opening 44 and a recessdepth 52. As used herein, the recess depth 52 is the greatest diameteracross the cavity 48 that is generally perpendicular to the recessopening 44. In some embodiments, the recess depth is great enough sothat the recess forms a natural flexion point in the tray, allowing thetray 30 to flex along the long axis of the recess. In some embodiments,a recess 42 may assume a generally vertical orientation in the lingualsurface 40 so that the long axis of the recess 42 generally aligns withthe z-axis of the tray 30. In such embodiments, the recess can providethe tray 30 with structural flexibility that permits the tray 30 and,therefore, the mouthguard 10 to flex to comfortably accommodate greatvariation in the maxillary arches among users. Such flexibilitygenerally increases as the number of generally vertical recesses 42increases in the lingual surface 40 of the tray 30, at least within therange of generally vertical recesses 42 typically present in amouthguard 10

The trough 20 is generally arched so that it is able to accept at leasta portion of a maxillary arch of a user and, optionally, at least aportion of the user's gums. The trough 20 includes a generally archedwall 22 that includes a lingual surface 24 and a facial surface 26. Thefacial surface 26 includes at least one member 28 protruding from thefacial surface 26. The member 28 is positioned and shaped to fit withinat least a portion of at least one recess 42 in the lingual surface 40of the tray 30.

The trough 20 can include any number of members 28. In some embodiments,the trough 20 will have no more members 28 than the tray 30 has recesses42. Thus, often, each recess 42 in the lingual surface 40 of the tray 30can accept a corresponding member 28 protruding from the facial surface26 of the trough 20, although it is not necessary that each recess 42have a corresponding member 26. Consequently, the trough 20 can includetwo, three, four, five, six, seven, eight, nine, ten, 11, 12, 13, 14,15, 16, 17, 18, 19, or 20 members 28. In embodiments that includemultiple members 28, the size, shape, and/or disposition on the facialsurface 26 of each member 28 may be independent of the size, shape,and/or disposition on the facial surface 26 of any other member 28.

A member 28 can assume a variety of shapes, sizes, orientations, and/ordispositions along the facial surface 26 of the trough 20. Typically,the size, shape, orientation, and/or disposition along the facialsurface 26 of the trough 20 will generally correspond to the size,shape, orientation, and/or disposition of recesses 42 on the lingualsurface 40 of the tray 30.

-   Accordingly, a member 28 can have any suitable shape. In some    embodiments, a member 28 may be generally circular or ovoid. In    other embodiments, a member 28 may be polygonal such as, for    example, generally rectangular, pentagonal, hexagonal, etc.

In addition to the male-female fit of the one or more members 28 intothe one or more corresponding recesses 42, the tray 30 and the trough 20may be attached, affixed, adhered, or otherwise assembled to one anotherin any suitable manner.

Heat-Softenable Material

The heat-softenable material may be any suitable material that softensand becomes moldable when heated to a temperature between about 120° F.and 200° F. Suitable heat-softenable materials can therefore besoftenable within a glass transition temperature range of as low as 120°F. to as high as about 200° F. such as, for example, within a glasstransition temperature range of, for example, from about 140° F. toapproximately 185° F. or 190° F.

Suitable materials include, for example, low melt temperature ethylenevinyl acetate (EVA) thermoplastics. In some embodiments, theheat-softenable material softens sufficiently for deformation to receivethe impression of teeth after being immersed in water at a temperaturerange of approximately 140° F. to approximately 180° F. forapproximately two minutes.

In some embodiments, the heat-softenable material can include apolycaprolactone such as, for example, polycaprolactone CAPA 6500(Perstorp UK, Ltd., Cheshire, UK) or TONE (P-767, Union CarbideCorporation, Piscataway, N.J.). A polycaprolactone may be used alone or,for example, in a mixture with EVA. In other embodiments, theheat-softenable material can include a mixture of polycaprolactone and apolyolefin elastomer such as, for example, a copolymer of ethylene andoctene-1 (e.g., ENGAGE, Dupont Canada, Inc., Mississauga, Ontario). Inother embodiments, the heat-softenable material may be a thermoplasticolefin such as, for example ADFLEX (LyondellBasell Industries N. V.,Rotterdam, Netherlands). In other embodiments, the heat-softenablematerial may be a thermoplastic polyurethane having a low melt point(e.g., less than 160° F.) such as, for example, certain TEXINthermoplastic polyurethanes (Bayer A G, Leverkusen, Germany). In stillother embodiments, the heat-softenable material may be a thermoplasticpolyolefin such as, for example, EXACT (ExxonMobil Chemical Co.,Houston, Tex.).

Non-Softenable Material

The non-softenable material may be any suitable material that does notappreciably softens and remains substantially unmoldable when heated toa temperature of about 200° F. Suitable non-softenable materials includethermoplastic materials such as, for example, higher melt temperaturethermoplastics including, for example, certain EVA copolymer resins suchas ELVAX 250 or ELVAX 260. In some embodiments, the non-softenablematerial may have a Shore “A” hardness of approximately 82, which canprovide a durable, rubbery material.

In some embodiments, the non-softenable material can include a mixtureof styrene block copolymer and high-density polyethylene (RIME). Morespecifically, the styrene block copolymer may include DYNAFLEX (partnumber G2780-0001 from GLS Corporation, McHenry, Ill.) while the HDPEmay include HD-6706 ESCORENE (ExxonMobile Chemical Co., Houston, Tex.).

In another embodiment, the non-softenable material can include a styreneblock copolymer mixed with polyolefin elastomer, which is a copolymer ofethylene and octene-1. A suitable copolymer is available as ENGAGE(Dupont Canada, Inc., Mississauga, Ontario).

In another embodiment, the non-softenable material can include a mixtureof thermoplastic rubber and a polyolefin elastomer as described above.Suitably thermoplastic rubbers include, for example, SANTOPRENE(ExxonMobile Chemical Co., Houston, Tex.) and KRATON ThermoplasticRubber (Kraton Polymers U.S. LLC, Houston, Tex.)

In other embodiments, the non-softenable material can include athermoplastic polyurethane having a relative high melt point (e.g.,greater than 180° F.) and a durometer at or above 90A and/or 40D.Thermoplastic polyurethanes suitable for use as the non-softenablematerial include, for example, certain TEXIN thermoplastic polyurethanes(Bayer A G, Leverkusen, Germany).

In still other embodiments, the non-softenable material can include asaturated elastomeric base styrenic (SEBS) such as, for example, UNISOFT(United Soft Plastics, Inc., Lawrenceville, Ga.).

For any method disclosed herein that includes discrete steps, the stepsmay be conducted in any feasible order. And, as appropriate, anycombination of two or more steps may be conducted simultaneously.

The complete disclosure of all patents, patent applications, andpublications, and electronically available material cited herein areincorporated by reference in their entirety. In the event that anyinconsistency exists between the disclosure of the present applicationand the disclosure(s) of any document incorporated herein by reference,the disclosure of the present application shall govern.

The foregoing detailed description, drawings, and examples have beengiven for clarity of understanding only and represent merely exemplaryembodiments. Thus, no unnecessary limitations are to be understood fromthe description, drawings, and examples. The invention is not limited tothe exact details shown and described, for variations obvious to oneskilled in the art will be included within the invention defined by theclaims.

Unless otherwise indicated, all numbers expressing quantities ofcomponents, molecular weights, and so forth used in the specificationand claims are to be understood as being modified in all instances bythe term “about.” Accordingly, unless otherwise indicated to thecontrary, the numerical parameters set forth in the specification andclaims are approximations that may vary depending upon the desiredproperties sought to be obtained by the present invention. At the veryleast, and not as an attempt to limit the doctrine of equivalents to thescope of the claims, each numerical parameter should at least beconstrued in light of the number of reported significant digits and byapplying ordinary rounding techniques.

Notwithstanding that the numerical ranges and parameters setting forththe broad scope of the invention are approximations, the numericalvalues set forth in the specific examples are reported as precisely aspossible. All numerical values, however, inherently contain a rangenecessarily resulting from the standard deviation found in theirrespective testing measurements.

All headings are for the convenience of the reader and should not beused to limit the meaning of the text that follows the heading, unlessso specified.

What is claimed is:
 1. A mouthguard comprising: a tray formed from anon-softenable material and comprising: an arched wall comprising a top,a bottom, a lingual surface, and a facial surface; and at least onegenerally vertical recess in at least a portion of the lingual surface;and a generally arched trough formed from a heat-softenable material andcomprising: an arched wall comprising a lingual surface and a facialsurface; and at least one member protruding from the facial surfacepositioned and shaped to fit within the at least one recess of the tray.2. The mouthguard of claim 1 wherein at least one recess extends to thetop of the lingual surface.
 3. The mouthguard of claim 1 wherein atleast one recess extends to the bottom of the lingual surface.
 4. Themouthguard of claim 1 wherein a cross section of the recess defines: anopening in the lingual surface having a lingual surface width; and acavity having a cavity width that is generally parallel to the lingualsurface width.
 5. The mouthguard of claim 4 wherein the cavity width isgreater than the surface width.
 6. The mouthguard of claim 1 wherein across section of the recess defines: an opening in the lingual surface;and a recess depth generally perpendicular to the lingual surface,wherein the recess depth is great enough to permit the tray to flex in aplane generally axial to the recess.
 7. The mouthguard of claim 1wherein fit of the trough member into the tray recess reducesdelamination of the trough from the tray.